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There’s a lot of ways to leave a good impression

Tuesday, October 10, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

There is no better learning opportunity than to observe an experienced individual correctly complete a process that you are trying to understand/implement outside of a classroom in a real-world environment. It lends depth to the sometimes-lifeless instruction of written curriculum. The demonstration tames the daunting unknown, creating confidence in an ability where there may have been none. It shows diversity of technique and timing, and expands that which is preconceived about an untried task.

An especially memorable training process for CRAs is the observation sign off monitoring visit. This occurs when a new CRA is signed off on independent conduct of one of the four monitoring visit types. It is historically a two- part process. The designated visit type is always initially observed so there can be no doubt as to visit completion requirements by the new CRA. Their performance is not only considered by their line manager and prospective project team, but also by the CRA that spent extra time preparing to observe the trainee (the protocol, monitoring tools, travel/site information) and the investigational site that graciously allowed their attendance and found space to accommodate.

A close colleague was once asked if a CRA could observe her conduct an evaluation visit at a research site for an infectious disease study. The project team was in desperate need of Midwest monitors; the CRA assigned to observe was being considered for the project and the observation would provide exposure to study activities.

The CRA observing was supposed to fly in the night before the visit. My colleague agreed to pick him up from the airport, drop him off at his hotel and pick him up the next morning for the monitoring visit. At the last minute he decided to change his flight to the next day. My colleague still agreed to pick him on her way to the site. She then had to apologize to the study coordinator and plead for a later start to the evaluation visit when the CRA’s flight was delayed almost 90 minutes.

The CRA observing did not apologize for the change even after my colleague explained the inconvenience his decision had caused and the possible implication to future site relations. The delay could have caused visit cancellation at considerable loss of time, resources and cost to all parties involved. Even worse, when they arrived at the site and began study discussions, the CRA spent a portion of the time on his smartphone checking email and distracting the process.

At the conclusion of the visit my colleague apologized profusely to the investigator, assuring them this was not a reflection of the company and quality practices. Fortunately the site had worked with the company quite successfully on other trials and understood this situation was an exception. My colleague had a frank discussion about the CRA’s behavior to his line manager. He was not selected to work on the study and given a strong reminder of professional conduct.

I have had very positive experiences with observation visits. Once, I was assigned to an evaluation visit at a local cardiology site and was asked by a line manager if a newer CRA could observe me, as she had not yet been signed off on evaluation visit conduct. I agreed, but before I had the chance to reach out to the CRA with the visit particulars, she emailed me to introduce herself. She thanked me for allowing her to observe and requested the protocol and ancillary materials so that she could adequately prepare. I requested that she meet me in the site building lobby 20 minutes prior to the visit start so that we could discuss the evaluation visit process and her understanding. I provided her with the site address and concluded the correspondence with positive anticipation.

The morning of the evaluation visit, I arrived 30 minutes early. I walked into the lobby of the medical office building that housed the investigational to find the CRA waiting eagerly.

I told her my plan for site evaluation and discussed an important, yet often overlooked, dynamic involved in site assessment. The CRA is not the only one evaluating. The site is also evaluating the CRA, an equally reciprocal consideration. The CRA is the direct sponsor representative, the first contact the site has, and their behavior will establish the overall site’s impression of the sponsor. How the site is treated at the inception of the relationship will influence that desire to participate in the study, to resolve any subsequent barriers to participation that may have stayed prohibitive were the CRA unprepared and unprofessional. If the relationship starts on a positive note, there is a strong likelihood that momentum will continue through selection, and study startup.

She soaked it up like a sponge, and took notes throughout the visit. She was courteous to staff members and made several helpful observations during the facilities tour. She even thanked the study coordinator and investigator for allowing the learning opportunity. She was inspirational.

It takes more than monitoring proficiency to make a good CRA. It requires strong interpersonal skills to build the site management dynamic that promotes quality and collaboration with investigational sites, proving that the start of every process is as important as the actual process itself.


Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She also is author of the novella Clinical Research Trials and Triumphs. Currently she works in relationship development/study startup in the CRO industry. Email ebwcra@yahoo.com or tweet @ebwcra.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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